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tory Commission has entered into an Act of 1974 (88 Stat. 1244),' any State effective agreement under subsection or any political subdivision of or any 274b. of the Act. “Non-agreement political entity within a State, any forState” means any other State;
eign government or nation or any po(d) “Byproduct material" means any litical subdivision of any such governradioactive material (except special ment or nation, or other entity; and nuclear material) yielded in or made (2) any legal successor, representative, radioactive by exposure to the radi agent, or agency of the foregoing; ation incident to the process of pro (1) “Physician" means an individual ducing or utilizing special nuclear ma licensed by a State or territory of the terial;
United States, the District of Colum(e) “Commission” means the Nuclear bia or the Commonwealth of Puerto Regulatory Commission and its duly Rico to dispense drugs in the practice authorized representatives;
of medicine; (f) “Curie" means that amount of ra- (m) “Production facility” means prodioactive material which disintegrates duction facility as defined in the reguat the rate of 37 billion atoms per lations contained in Part 50 of this second;
chapter; (g) “Government agency” means any (n) “Radiographer" means any indiexecutive department, commission, in- vidual who performs or who, in atdependent establishment, corporation, tendance at the site where the sealed wholly or partly owned by the United source or sources are being used, perStates of America which is an instru sonally supervises radiographic opermentality of the United States, or any ations and who is responsible to the liboard, bureau, division, service, office, censee for assuring compliance with officer, authority, administration, or the requirements of the Commission's other establishment in the executive regulations and the conditions of the branch of the Government;
license; (h) “Human use" means the internal (0) "Radiographer's assistant" or external administration of byprod- means any individual who, under the uct material, or the radiation there personal supervision of a radiofrom, to human beings;
grapher, uses radiographic exposure (i) “License”, except where other devices, sealed sources or related hanwise specified means a license for by. product material issued pursuant to The Department facilities and activities the regulations in this part and Parts identified in section 202 are: 31 through 35 of this chapter;
(1) Demonstration Liquid Metal Fast (j)(1) “Microcurie" means that Breeder reactors when operated as part of amount of radioactive material which
the power generation facilities of an electric disintegrates at the rate of 37 thou
utility system, or when operated in any
other manner for the purpose of demonsand atoms per second;
strating the suitability for commercial ap(2) “Millicurie" means that amount plication of such a reactor. of radioactive material which disinte (2) Other demonstration nuclear reactors, grates at the rate of 37 million atoms except those in existence on January 19. per second;
1975, when operated as part of the power (k) “Person” means: (1) Any individ
generation facilities of an electric utility
system, or when operated in any other ual, corporation, partnership, firm, as
manner for the purpose of demonstrating sociation, trust, estate, public or pri
the suitability for commercial application of vate institution, group, Government
such a reactor. agency other than the Commission or (3) Facilities used primarily for the receipt the Department, except that the De and storage of high-level radioactive wastes partment shall be considered a person
resulting from licensed activities. within the meaning of the regulations
(4) Retrievable Surface Storage Facilities in this part to the extent that its facil
and other facilities authorized for the ex
press purpose of subsequent long-term storities and activities are subject to the li
age of high-level radioactive waste generatcensing and related regulatory author
ed by the Department, which are not used ity of the Commission pursuant to sec for, or are part of, research and develoption 202 of the Energy Reorganization ment activities.
(30 FR 8185, June 26, 1965, as amended at 36 FR 1466, Jan. 30, 1971; 37 FR 5746, Mar. 21, 1972; 38 FR 29314, Oct. 24, 1973; 40 FR 8784, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978; 45 FR 14200, Mar. 5, 1980; 45 FR 18905, Mar. 24, 1980)
8 30.5 Interpretations.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part and Parts 31 through 35 by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission. (Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841)) (30 FR 8185, June 26, 1965, as amended at 43 FR 6921, Feb. 17, 1978)
dling tools, or radiation survey instruments in radiography;
(p) “Radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of byproduct materials;
(q) “Research and development” means: (1) Theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. “Research and development” as used in this part and Parts 31 through 35 does not include the internal or external administration of byproduct material, or the radiation therefrom, to human beings;
(r) “Sealed source” means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material;
(s) "Source material” means source material as defined in the regulations contained in Part 40 of this chapter;
(t) "Special nuclear material" means special nuclear material as defined in the regulations contained in Part 70 of this chapter;
(u) “United States”, when used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States;
(V) "Utilization facility” means a utilization facility as defined in the regulations contained in Part 50 of this chapter;
(w) “Commencement of construction” means any clearing of land, excavation, or other substantial action that would adversely affect the natural environment of a site but does not include changes desirable for the temporary use of the land for public recreational uses, necessary borings to determine site characteristics or other preconstruction monitoring to establish background information related to the suitability of a site or to the protection of environmental values.
8 30.6 Communications.
(a) Unless otherwise specified, or covered under the regional licensing program as provided in paragraph (b) of this section, any communication or report concerning the regulations in Parts 30-35 of this chapter, and any application filed under these regulations may be submitted to the Commission as follows:
(1) By mail addressed to-Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
(2) By delivery in person to the Commission offices at
(i) 1717 H Street, NW., Washington, DC; or
(ii) 7915 Eastern Ave., Willste Bldg., Silver Spring, Maryland.
(b) The Commission is conducting a regional licensing program for selected parts of its material licensing program. Any communication, report, or application covered under the Commission's regional licensing program for Regions I and III must be submitted as specified in paragraph (b)(2) of this section.
(1) The regional licensing program includes,
(i) All licenses for the medical use of radioisotopes except teletherapy sources and nuclear powered pacemakers;
(Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841))
(ii) All academic licenses except irra that its activities are subject to the rediators;
quirements of Part 60 of this chapter. (iii) All industrial licenses author
(Sec. 161, as amended, Pub. L. 83-703, 68 izing research and development;
Stat. 948 (42 U.S.C. 2201); sec. 201, as (iv) Licenses for the industrial use of
amended, Pub. L. 93-438, 88 Stat. 1243 (42 stationary and portable gauges; and
U.S.C. 5841); secs. 11.e(2), 81, 83, 84, 161b, (v) Licenses of sources contained in
1610, 161x, 274; Pub. L. 83—703 as amended gas chromatographs and x-ray fluores by Title II of Pub. L. 95–604, 68 stat. 919 et cence analyzers.
seq. 92 stat. 3021 et seq. (42 U.S.C. 2014e(2). (2) The following regions are partici. 2111, 2113, 2114, 22016, 2201x, 2021)) pating in the regional licensing pro
(37 FR 5746, Mar. 21, 1972, as amended at gram.
39 FR 26279, July 18, 1974; 40 FR 8784, Mar. (i) Region I. With the exception of 3, 1975; 43 FR 6921, Feb. 21, 1978; 45 FR Federal facilities and the District of 65530, Oct. 3, 1980; 46 FR 13979, Feb. 25, Columbia, the regional licensing pro 1981) gram involves the following Region I Non-Agreement States: Connecticut, $ 30.12 Persons using byproduct material Delaware, Maine, Massachusetts, New under certain Department of Energy Jersey, Pennsylvania, and Vermont. and Nuclear Regulatory Commission All inquiries and each application for contracts. a new license or an amendment or re
Except to the extent that Departnewal of an existing license specified
ment facilities or activities of the in paragraph (b)(1) of this section may
types subject to licensing pursuant to be sent to-U.S. Nuclear Regulatory
section 202 of the Energy ReorganizaCommission, Region I, Material Li
tion Act of 1974 are involved, any censing Section, 631 Park Avenue,
prime contractor of the Department is King of Prussia, Pennsylvania 19406.
exempt from the requirements for a li(ii) Region III. With the exception
cense set forth in sections 81 and 82 of of Federal facilities, the regional licensing program involves the follow
the Act and from the regulations in ing states: Illinois, Indiana, Iowa,
this part to the extent that such con
tractor, under his prime contract with Michigan, Minnesota, Missouri, Ohio, and Wisconsin. All inquiries and each
the Department manufactures, proapplication for a new license or an
duces, transfers, receives, acquires, amendment or renewal of an existing
owns, possesses, or uses byproduct malicense specified in paragraph (b)(1) of
terial for: (a) The performance of this section may be sent to-U.S. Nu
work for the Department at a United clear Regulatory Commission, Region
States Government-owned or conIII, Radioisotopes Licensing Section,
trolled site, including the transporta799 Roosevelt Road, Glen Ellyn, Illi
tion of by-product material to or from nois 60137.
such site and the performance of con(46 FR 44419, Sept. 4, 1981)
tract services during temporary interruptions of such transportation; (b) re
search in, or development, manufacEXEMPTIONS
ture, storage, testing or transportation
of, atomic weapons or components 8 30.11. Specific exemptions.
thereof; or (c) the use or operation of (a) The Commission may, upon ap- nuclear reactors or other nuclear de
ation of any interested person or vices in a United States Governmentupon its own initiative, grant such ex owned vehicle or vessel. In addition to emptions from the requirements of the foregoing exemptions and subject the regulations in this part and Parts to the requirement for licensing of De31 through 35 of this chapter as it de- partment facilities and activities purtermines are authorized by law and suant to section 202 of the Energy Rewill not endanger life or property or organization Act of 1974, any prime the common defense and security and contractor or subcontractor of the Deare otherwise in the public interest. partment or the Commission is (b) (Reserved)
exempt from the requirements for a li. (c) The DOE is exempt from the re- cense set forth in sections 81 and 82 of quirements of this part to the extent the Act and from the regulations in
this part to the extent that such prime contractor or subcontractor manufacturers, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material under his prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety. (Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841)) (40 FR 8784, Mar. 3, 1975, as amended at 43 FR 6921, Feb. 17, 1978)
an agreement State is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part and Parts 31, 32, 33, and 34 of this chapter to the extent that he transfers byproduct material contained in a product or material in concentrations not in excess of those specified in § 30.70 and introduced into the product or material by a licensee holding a specific license issued by an agreement State, the Commission, or the Atomic Energy Commission expressly authorizing such introduction. This exemption does not apply to the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
(d) No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this section or equivalent regulations of Agreement State, except in accordance with a license issued pursuant to $ 32.11 of this chapter or the general license provided in $ 150.20 of this chapter. (Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841)) (30 FR 8185, June 26, 1965, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978)
$ 30.13 Carriers.
Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the regulations in this part and Parts 31 through 35 of this chapter and the requirements for a license set forth in section 81 of the Act to the extent that they transport or store byproduct material in the regular course of carriage for another or storage incident thereto.
(Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841)) [37 FR 3985, Feb. 25, 1972, as amended at 43 FR 6921, Feb. 17, 1978)
§ 30.14 Exempt concentrations.
(a) Except as provided in paragraphs (c) and (d) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part and Parts 31 through 35 of this chapter to the extent that such person receives, possesses, uses, transfers, owns or acquires products or materials containing byproduct material in concentrations not in excess of those listed in § 30.70.
(b) This section shall not be deemed to authorize the import of byproduct material or products containing byproduct material.
(c) A manufacturer, processor, or producer of a product or material in
8 30.15 Certain items containing byprod.
uct material. (a) Except for persons who apply byproduct material to, or persons who incorporate byproduct material into, the following products, or persons who initially transfer for sale or distribution the following products containing byproduct material, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in Parts 20 and 30 through 35 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:
(1) Timepieces or hands or dials containing not more than the following specified quantities of byproduct ma
terial and not exceeding the following specified levels of radiation:
(i) 25 millicuries of tritium per timepiece,
(ii) 5 millicuries of tritium per hand,
(iii) 15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial),
(iv) 100 microcuries of promethium 147 per watch or 200 microcuries of promethium 147 per any other timepiece,
(v) 20 microcuries of promethium 147 per watch hand or 40 microcuries of promethium 147 per other timepiece hand,
(vi) 60 microcuries of promethium 147 per watch dial or 120 microcuries of promethium 147 per other time. piece dial (bezels when used shall be considered as part of the dial),
(vii) The levels of radiation from hands and dials containing promethium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:
(a) For wrist watches, 0.1 millirad per hour at 10 centimeters from any surface,
(6) For pocket watches. 0.1 millirad per hour at 1 centimeter from any surface,
(c) For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.
(2) Lock illuminators containing not more than 15 millicuries of tritium or not more than 2 millicuries of promethium 147 installed in automobile locks. The levels of radiation from each lock illuminator containing promethium 147 will not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber.
(3) Balances of precision containing not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part.
(4) Automobile shift quadrants containing not more than 25 millicuries of tritium.
(5) Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas.
(6) Thermostat dials and pointers containing not more than 25 millicuries of tritium per thermostat.
(8) Electron tubes: Provided, That each tube does not contain more than one of the following specified quantities of byproduct material:
(i) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;
(ii) 1 microcurie of cobalt-60; (iii) 5 microcuries of nickel-63; (iv) 30 microcuries of krypton-85; (v) 5 microcuries of cesium-137; (vi) 30 microcuries of promethium147; And provided further, That the levels of radiation from each electron tube containing byproduct material do not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber.'
(9) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of byproduct material: Provided, That;
(i) Each source contains no more than one exempt quantity set forth in $ 30.71, Schedule B, and
(ii) Each instrument contains no more than 10 exempt quantities. For purposes of this paragraph (a)(9), an instrument's source(s) may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in § 30.71, Schedule B, provided that the sum of such fractions shall not exceed unity.
(iii) For purposes of this paragraph (a)(9), 0.05 microcurie of americium241 is considered an exempt quantity under $ 30.71, Schedule B.
(10) Spark gap irradiators containing not more than 1 microcurie of cobalt
'For purposes of this paragraph "electron tubes" include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.